Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | Documents & Resources
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Documents & Resources

Tiered In Vitro Testing Strategy For Assessing The Ocular and Dermal Irritation/Corrosion Potential of Pharmaceutical Compounds

July 23, 2018

Read our latest publication with Bristol-Myers Squibb regarding a tiered testing strategy for occupational hazards of pharmaceutical intermediates now published in the Cutaneous and Ocular Toxicology Journal. Irritation reactions are a frequently reported occupational illness. The potential adverse effects of pharmaceutical compounds (PCs) on employees' eyes and skin can now be assessed using validated in vitro methods. Our overall aim is to reduce animal testing by replacing the historically utilized in vivo test methods with validated in vitro test methods which accurately determine the ocular and dermal irritation/corrosion potential of PCs to inform worker safety within the pharmaceutical space. BMS and IIVS have therefore conceptualized and internally qualified a tiered in vitro testing strategy to inform occupational hazards regarding eye and skin irritation and corrosivity of PCs. which is based on three Organisation for Economic Co-operation and Development (OECD) in vitro methods (OECD TG 435, OECD TG 437, OECD TG 439.) Read the full article.  

Next-Generation Tobacco and Nicotine Products: Substantiating Harm Reduction and Supporting Tobacco Regulatory Science

June 21, 2018

A framework for the assessment of novel next-generation tobacco and nicotine products with the potential to reduce health risks compared with cigarettes should integrate scientific studies incorporating nonclinical, clinical, and population studies approaches.  These products should have lower emissions and exhibit reduced biological effects compared with those of cigarettes, ideally approaching those of smoking cessation.  The products should also be acceptable cigarette alternatives for current smokers, while not appealing to nonsmokers or former smokers.  Validating harm reduction and promoting regulatory acceptance of the assessment methods require a collaborative approach by industry, independent reviewers, the public health community, and regulatory agencies.  This article summarizes the science and approaches applied and considered to substantiate tobacco harm reduction in the light of regulatory requirements. Read the full article.  

Characterization of a Vitrocell VC1 Using Nicotine Dosimetry: An Essential Component Toward Standardized In Vitro Aerosol Exposure of Tobacco and Next Generation Nicotine Delivery Products

June 21, 2018

The U.S. Food and Drug Administration has regulatory authority over tobacco products, including conventional cigarettes and next generation products (NGPs) such as e-cigarettes and tobacco heating products (THPs).  There is a desire by the industry,  regulator and animal, protection organizations to incorporate non-animal test methods for tobacco product and NGP assessment.  When assessing respiratory effects in vitro, reliable exposure systems that deliver aerosols to cellular/tissue cultures (such as human reconstructed airways or lung slices) at the air–liquid interface are needed.  Using nicotine dosimetry, we report the characterization of a Vitrocell VC1 in our laboratories (IIVS, USA).  Nicotine, generated from a 3R4F reference cigarette or NGP (e-cigarette and THP) aerosols at source and the exposure interface (culture media), was assessed using ultra-high-performance liquid chromatography–tandem mass spectrometry.  These data were compared to published dosimetry data for the same products, generated at a different laboratory (BAT R&D, Southampton, UK), on different exposure systems (VC10 and Borgwaldt RM20S) to confirm repeatability. Read the full article.  

Know Your Skin Cells: III. The Melanocytes

February 1, 2018

IIVS toxicologist and study director, Emilia Costin wrote about melanocytes, responsible  for producing skin color for The Cosmetic Chemist. Read article

IIVS BCOP Training Video – Spanish

October 16, 2017

This 13- minute video demonstrates how to perform the BCOP assay according to the Test Guidelines set forth for the assay by the Organization for Economic Co-operation and Development (OECD TG 437). The video focuses on steps that are critical to the success of the assay such as handling of the isolated cornea and removal of the test material from the cornea at the conclusion of the exposure time...

The 3T3 Neutral Red Uptake Phototoxicity Test – Spanish

October 6, 2017

This new training video explores a cell-based method for assessing Phototoxicity - or the potential for chemicals to cause damage after being exposed to light. The method is used widely around the world by many industries, including the cosmetics and pharmaceutical sectors. Disclaimer: Please note that the procedures shown in this video were for demonstration ...

Quality Considerations: Redefining Test Systems from Animals to Tissues and Beyond

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10) A.K. Ulrey, RQAP-GLP; H.A. Raabe, M.S. The use of non-whole animal test methods transforms the way regulatory requirements are applied in preclinical testing. Recent global regulatory initiatives emphasize the importance of transitioning to human relevant assays and test systems that do not use animals. When these methods are moved from research into the regulated arena, GLP principles must be followed. The GLPs were originally written in the 1970s, when the vast majority of regulated research was performed using animals as the test system. Current innovative, alternative test systems include ex vivo tissues, manufactured biological systems, three dimensional tissue constructs, and cell cultures maintained in dynamic flow bioreactors. Each type of alternative test system raises new quality and compliance points to consider when used within a regulatory context. Just as the applications of these methods have advanced with regulatory acceptance, the quality control and compliance of these test systems must also progress.

Introducing the 3R Concepts into Pre-College Classrooms

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10)

N. Green, G.-E. Costin, A. Miller, S. Leary, K. Lewis    This poster provides a snapshot of precollege teachers (46) within the U.S.—gauging their knowledge and familiarity of the 3Rs and non-animal testing methods (i.e. in vitro methods), initiative to address the topic in the classroom, and their students’ level of interest in the topic. While recognizing the ethical considerations related to animal experimentation, the current generation of teachers and students are also eager to understand the relevance, reliability, and reproducibility of in vitro methods as the modern wave of technologies in toxicology, and possible replacement of animal use for testing purposes. Our data indicate an education field eager to learn about new concepts that might impact our daily activities in an ethical way, and to get up to speed with advances in science.

Non-Animal Testing Approach to Address Biocompatibility Testing of Medical Devices Required by the United States Food and Drug Administration (US FDA)

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10)

E. Hill, R. Curren, and G.-E. Costin Starting in December 2015, personal lubricants must receive pre-market approval from the US FDA Center for Devices and Radiological Health (CDRH) in order to be sold in the US. Part of the testing battery for biocompatibility includes the in vivo Rabbit Vaginal Irritation (RVI) test. We have created an Industry Consortium comprised of personal lubricants manufacturers and are working collaboratively with stakeholders and the US FDA to develop an in vitro testing approach to substitute for the RVI. Our Validation Program will analyze paired in vivo-in vitro data for vaginal irritation utilizing commercially available human reconstructed vaginal tissue models. A Prediction Model will be proposed that can be used for the safety assessment of personal lubricants. Our Validation Program proposal has been accepted in the Incubator Phase of the US FDA Medical Device Development Tool (MDDT) Pilot Program and is currently ongoing.

In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use

August 17, 2017

In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed ‘modified risk’. On April 4-6, 2016, IIVS convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP. This report includes the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapor exposures. Full article available to full and paid subscribers of ATLA.